What is FDA Quality System Regulation (QSR)?

The quality system regulations are for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (cGMP’s). It is a quality system that is necessary component of any medical device manufacturer seeking regulatory clearance or approval from FDA to commercialize their product in the US. It is necessary for themanufacturer to meet 21 CFR Part 820 requirements of US Code of Federal Regulations, known as the QSR tobring their products to the US market.

Relationship Between FDA QSR 21 CFR 820 and International Standard, ISO 13485:2016

The ISO 13485:2016 and Food and Drug Administration (FDA) QSR 21 CFR 820 have several differences, which is what have kept them from harmonizing in the past.

  • ISO 13485:2016 is a standard based upon ISO 9001:2008 and is specific to the design and manufacture of medical devices. This standard is projected to be adopted by the Food and Drug Administration (FDA) in 2019.
  • Title 21 CFR 820 is the current quality system for medical devices used by the FDA. The FDA enforces this title currently, but they plan to ultimately move from 21 CFR 820 to ISO 13485:2016 which will simplify the QMS of companies seeking FDA approval for their medical devices and makes it easier for international trade.
  • If a company meets the requirements of ISO 13485:2016, they should easily be able to meet the FDA’s Quality System Regulation requirements.

Where do they each apply?

  • The ISO 13485 is a global standard that is voluntary in the US market but required in some countries.
  • The ISO 13485 will become the FDA’s mandatory QMS April of 2019. Third party registrars or Certifying Bodies(CBs) conduct audits to ensure conformance.
  • The FDA enforces 21 CFR 820, but the new MDSAP will allow CB’s to audit FDA guidelines as of 2018.
  • The FDA’s 21 CFR 820 is applicable to manufacturers of finished medical devices sold in the United States, including imported products. Only parts of the regulatory requirement may be applicable depending on the class of the medical device.

Harmonizing FDA QSR requirements with ISO 13485:2016

The US Food and Drug Administration was planning to revise its current Quality System Regulations (QSR) under 21 CFR Part 820 to align with the international standard more closely, ISO 13485:2016. The ISO 13485 quality standard forms the basis for qualitymanagement system requirements in the European Union, Japan, Canada, and other regulated medical device markets. FDA was planning to issue a notice of proposed rulemaking in October 2020 establishing US quality system requirements based more closely on ISO 13485:2016, according to the FDA’s Rule List.

Through the proposed rule, FDA intends to provide less onerous pathways for manufacturers of medical device to the market that currently must meet significant FDA QSR requirements particular to the US to obtain 510(K) premarket notification, De Novo, or Premarket Approval (PMA) registration.

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